http://www.epva.org/MSQR_Archive/Spring02_6.htm
Clinical Trials Open for Enrollment
MSQR - V21. N1. Spring 2002
AndroGel® (Testosterone Gel) Study
Location: Joint study of UCLA MS Research Center and Harbor UCLA,
Los Angeles, CA
Purpose: Open-label study to determine whether treatment with
testosterone causes any harmful side effects not related to MS and to obtain
information concerning the effectiveness of testosterone treatment in men
with MS.
Eligibility: 12 male subjects
Procedures: Screening visits followed by 6-month pre-treatment
phase, 12-month treatment phase, and an exit visit. Monthly magnetic resonance
imaging (MRI) as well as visits every 3 months to monitor condition. Visits
will be made to both facilities during the course of the study.
Benefit: Frequent, careful monitoring of medical condition. Participants
may or may not benefit from taking the testosterone.
For Information: Contact Ricki Klutch at the UCLA MS Research
Center at (310) 825-7313, or via e-mail: rklutch @ ucla.edu.
Antegren® (Natalizumab) Phase III Trial for RRMS
Location: International multi-centers in the US, Canada, Europe,
South America
Purpose: To determine the effectiveness in reducing the rate
of clinical relapses in MS, in slowing the progression of disability associated
with MS, and in attenuating the number of brain lesions viewed on repeat
MRI scans.
Eligibility: Women and men between the ages of 18 and 50 who
have a diagnosis of relapsing-remitting MS and have experienced at least
one medically documented relapse within 12 months prior to starting the
study. Participants must not have taken Avonex®, Betaseron®, or
Copaxone® for 6 months previous to study enrollment.
Procedures: Participants will receive intravenous infusions
of either the study drug or placebo every 4 weeks for approximately 2 years.
Two-thirds of study participants will receive study medication, one-third
will receive placebo. Participants will undergo three MRIs during the study.
Benefit: This phase III trial may lead to a new FDA-approved
therapy that enhances the quality of life of persons with MS.
For Information: There are over 100 centers in this study, including
a great many in the US. Thus, please contact the center(s) in your area
to determine their involvement in this study and your possible participation
at that site.
Antibiotic Treatment Directed Against Chlamydia Pneumonia
Location: University of Texas Southwestern Medical Center, Dallas,
TX
Purpose: To see if treatment with antibiotics in CSF chlamydia
positive individuals with MS will decrease lesion burden on MRI.
Eligibility: Participants must have clinically definite MS with
EDSS scores between 1.0 and 3.5, age between 19 and 65, evidence of C.
pneumonia infection in CSF by satisfying at least one of two criteria (positive
CSF by PCR for C. pneumonia MOMP gene or antibody titer at least 2.5 times
greater than background or positive culture), two enhancing lesions on
MRI, no allergy to azithromycin and rifampin, not pregnant or lactating,
adequate renal function (creatinine < 1.4 mg/dl), normal hepatic function,
no relapses within 90 days or steroids within 30 days.
Procedures: Participants will undergo lumbar puncture, screening MRI,
venous blood draws, repeat lumbar puncture and MRIs during trial.
Benefit: This study may result in a decrease in lesions and
relapses as well as a decrease in disability.
For Information: Contact Dr. Kathleen Hawker at the University
of Texas Southwestern Medical Center at (214) 648-9030.
Calpain Activation of T Cells in Demyelinating Disease
Location: Medical University of South Carolina (MUSC), Charleston,
SC
Purpose: To determine if beta-interferon has an effect on the
cellular expression of calpain, an enzyme believed to be involved in the
pathogenesis of MS.
Eligibility: Participants must have a diagnosis of definite
relapsing-remitting MS, be eligible for therapy with beta-interferon but
not yet started on treatment, and be able to travel to Charleston monthly
for a 6-month period including any relapses during this time.
Procedures: Blood will be collected at various time points before
and after the initiation of beta-interferon for calpain measurement from
T cells. Each study participant will be followed for 6 months.
Benefit: Participants will help to determine the mechanisms
of demyelination in MS.
For Information: Contact the MS Center at MUSC at (843) 792-3221.
Cannabinoids as a Therapy for Spasticity in MS
Location: Multi-centers in England
Purpose: To determine whether cannabinoids have a beneficial
therapeutic effect on spasticity in MS, and also beneficial effects on
pain, tremor, urination disturbance, and overall measures of quality of
life.
Eligibility: Patients with clinically definite or laboratory
supported MS, aged 18 to 64 years, significant spasticity in at least two
leg muscle groups, stable disease for last 6 months, and anti-spasticity
medication and PT stabilized for the last 30 days. Must reside within travel
distance of participating center. There are also exclusion criteria.
Procedures: Participants in the double blind, three-way controlled
trial will be assigned to one of four regimens:
delta 9-tetrahydracannabinol (THC), placebo capsules matching appearance
of THC, natural cannabis oil (Cannador) containing same dose of THC and
made up to GMP standard, or placebo capsules matching appearance of the
cannabis capsules. Patients to attend a total of 7 visits within the main
15-week trial, during which assessments of spasticity and mobility will
be made and side effects will be recorded. Participants will be adjusted
on their optimal current therapy before trial entry, then undergo a 5-week
titration phase and an 8-week maintenance phase before drug withdrawal.
Assessments of quality of life and disability will be made by mail questionnaire.
Benefit: This study may lead to a treatment for spasticity.
For Information: Contact Dr. J. P. Zajicek at Derriford Hospital
in Plymouth, England, via e-mail: john.zajicek @ phnt.swest.nhs.uk, or
via telephone at 011 + 44 + 01752 + 315252.
Cognitive Impairment Investigational Drug
Location: Multi-centers in the USA
Purpose: This study will investigate whether a drug shown to
improve cognition in persons with Alzheimer’s disease will also improve
cognition in MS. The drug being studied is currently approved only for
the treatment of mild to moderate dementia of the Alzheimer’s type. For
regulatory reasons, the names of the drug and sponsor have not been released.
Eligibility: Women and men aged 25 to 60 years with all forms
of MS, who have significant memory impairment. To complete the comprehensive
neuropsychological and cognitive tests involved in the study, all subjects
must be fluent in English, and a caregiver or family member must accompany
the participant on all study visits.
Procedure: After screening (possibly including MRI) to ascertain
eligibility for the trial, participants will receive daily oral medication
or inactive placebo for 12 weeks. Subjects will have a 50/50 chance of
receiving study medication or placebo during the study. Safety and clinical
assessments will be conducted at clinical visits every 3 weeks during the
trial, for a total of 4 visits once treatment begins. Procedures to evaluate
safety include blood tests, electrocardiograms (a tracing of the electrical
activity of the heart), physical exams, and vital signs. Treatment effects
will be evaluated based on differences between the treated and placebo
subjects on a variety of memory and other cognitive and neuropsychological
tests and scales.
Benefit: This study may lead to a new treatment for cognitive
impairment in MS.
For Information: Please call the following toll-free number
for a list of the approximately 20 U.S. clinical centers that are participating:
(866) 812-8547.
High-Dose Cyclophosphamide and Total Body Irradiation with T Lymphocyte-Depleted
Autologous Peripheral Blood Stem Cell or Bone Marrow Rescue
Location: Northwestern Memorial Hospital, Chicago, IL and Rush-Presbyterian-St.
Luke’s Medical Center, Chicago, IL
Purpose: Determine the efficacy, in terms of disease progression,
of high-dose cyclophosphamide and total body irradiation with T lymphocyte-depleted
autologous peripheral blood stem cell or bone marrow rescue in MS.
Eligibility: Male and female patient up to 59 years of age,
diagnosis of MS, Kurtzke score of 4.0 to 7.5 with increase of 1.0 point
over the past 12 months, more than 3 relapses in 24 months despite conventional
disease-modifying therapy, failure to stabilize active clinical progression
with a 3-day regimen of methylprednisolone.
Procedure: Following an induction course of cyclophosphamide
IV, patients receive filgrastim (G-CSF) subcutaneously (SC) daily until
the completion of peripheral blood stem cell (PBSC) harvesting over several
days. Patients who do not mobilize sufficient cells undergo bone marrow
harvest. Harvested PBSCs or bone marrow then undergo T lymphocyte depletion.
Receive cyclophosphmide IV over 1 hour on days –6 and –5 and methylprednisolone
IV daily days –4 to –1. Undergo total body irradiation twice a day on days
–4 to –1. Lymphocyte-depleted PBSCs or bone marrow is reinfused on day
0. Receive G-CSF SC daily beginning on day 0 and continue until blood counts
have recovered for 3 days. Patients are followed at 1, 2, 3, 6, and 12
months and then annually for 5 years.
Benefit: This Phase I study may ultimately lead to a new treatment
for MS.
For Information: At Northwestern, contact Ann Traynor at
(312) 908-5284 and at Rush-Presbyterian-St. Luke’s, call Floyd Davis
at (312) 942-5000.
Molecular Analysis of the IG Repertoire
Location: University of Texas Southwestern Medical Center, Dallas,
TX
Purpose: This study will explore the role of B cells in the pathogenesis
of MS.
Eligibility: Participants must have clinically definite MS.
Procedures: Participants will undergo venous blood draw and
lumbar puncture once a year for
3 years.
Benefit: This research may lead to new therapies in MS. Participants
will be compensated for their annual blood draw and lumbar puncture.
For Information: Contact Dr. Nancy Monson at the University
of Texas Southwestern Medical Center in Dallas at (214) 648-9030, or via
e-mail: nancy.monson @ utsouthwestern.edu.
MRI to Evaluate MS Activity
Location: National study sponsored by the National Institute
of Neurological Disorders and Stroke (NINDS), based in Bethesda, MD
Purpose: To identify immunological processes that may contribute to
the development of MS and to design specific therapies for the disease.
The effect of interferon beta-1b will be studied for its effect on RRMS
disease activity as measured by MRI.
Eligibility: Men and women with laboratory supported definite
MS or a relapsing-remitting course.
Procedures: Monitor MS disease activity over time via MRI with
gadolinium. MRI findings will be correlated with clinical status. Some
patients will also be studied by magnetization transfer (MT), along with
MRI in an effort to identify the metabolic changes occurring in acute lesions
of MS. MRI. Immunological studies will be done in parallel with the MRI
evaluation.
Benefit: Improve efforts to measure progression of MS, identify
immunological processes that contribute to the disease and design specific
therapies.
For Information: Contact the NIH Patient Recruitment and Public
Liaison Office via toll-free telephone at (800) 411-1222, or via e-mail:
prpl @ mail.cc.nih.gov.
Novantrone® and Avonex® (Interferon Beta-1a) or Novantrone® and Copaxone® (Glatiramer Acetate)
Location: University of Maryland in Baltimore, MD; Cleveland
Clinic, Cleveland, OH; Mt. Sinai School of Medicine in New York, NY; and
Yale MS Research Center in New Haven, CT
Purpose: Open-label study to determine tolerability of combining Novantrone
with either Avonex or Copaxone
Eligibility: Participants must be suboptimal responders to Avonex
or Copaxone and have worsening relapsing-remitting or secondary progressive
MS.
Procedures: Clinical examinations, blood samples, and MRI scans.
Benefit: To gain knowledge on tolerability of combination therapies
that have the potential (unproven) to improve response to single-agent
disease modifying therapy.
For Information: Contact the participating Center nearest to
you:
Baltimore, MD: (410) 328-5605
Cleveland, OH: (216) 444-6800 or (800) 223-2273
New Haven, CT: (203) 764-4285
New York, NY: (212) 241-4264
Novantrone® Safety, Quality of Life, and Cost of Illness Study
Location: Multi-centers in the US.
Purpose: To study the long-term safety of Novantrone (mitoxantrone)
and to evaluate the relationship between disease activity, progression
of disability or progression of handicap and quality of life and disease-related
costs among patients who participate in the Novantrone Safety Study.
Eligibility: Participants must have secondary progressive, progressive-relapsing,
or worsening relapsing-remitting MS; must be 18 to 65 years of age, have
normal WBC and platelet count; and not have any significant heart disease
or severe infection.
Procedure: All participants will receive standard Novantrone (mitoxantrone)
therapy, including 12 mg/m sq of mitoxantrone IV every 3 months for 3 years,
must have blood draw and urinalysis every 3 months, must have echocardiogram
(ultrasound of the heart) at outset and every 3 months in the last year
of the 3-year therapy and after therapy completed. The study is 3 years
of treatment followed by 2 years of follow-up of potential adverse effects,
for a total of 5 years. Participation does not preclude other treatments
for MS during the trial.
Participants also will be asked to complete a survey every 3 months
with questions about their disability status, fatigue, pain, and other
quality of life measures. In addition, also every 3 months, they will be
asked to record in a diary their MS-related symptoms and the various costs
incurred due to MS.
Benefit: Treatment with Novantrone may improve or stabilize
the patient’s MS. There is no direct benefit to participants in the quality
and cost portion of this project. However, this aspect of the research
study will help to acquire more knowledge about the quality of life and
the cost of disease for patients with multiple sclerosis who are treated
with Novantrone.
For Information: Contact RENEW Help Desk toll-free at (866)
736-3910, or Debbie Ruotolo at the Yale MS Research Center NARCOMS Project
at (203) 932-5711, ext. 5544, or via e-mail: Debbie.Ruotolo @ yale.edu.
Debbie will refer interested persons to the nearest participating center.
Rolipram to Treat RRMS and SPMS
Location: National study sponsored by the National Institute
of Neurological Disorders and Stroke (NINDS) based in Bethesda, MD
Purpose: To evaluate the safety, tolerability, and effect of Rolipram
on MS and to examine whether Rolipram can dampen the part of the immune
response believed to lead to MS and reduce disease activity.
Eligibility:
• Male and female between the ages of 18 and 65 years
• Clinically definite relapsing-remitting or secondary progressive
MS
• EDSS score between 4.0 and 6.5 for stage I and between 1.5 and 6.5
for stage II
• Must have either failed standard treatment (interferon beta, glatiramer
acetate) by clinical measures, not been eligible for any standard treatments
available or opted not to start/continue these treatments
• Must have an average of up to 2 Gd-enhancing lesions per month over
the 3 month pre-treatment baseline period for stage I and an average of
at least 0.5 Gd-enhancing lesions per month over the 4-month pre-treatment
period for stage II
• Must not have had a relapse during 30 days before initiation of treatment.
Procedures: Candidates will be screened with a complete neurological
and medical evaluation. During the 3-month baseline period, approximately
4 MRI scans will be obtained and participants with MS activity above a
certain level will continue with the treatment phase.
During the 8-month treatment phase, participants will take Rolipram
tablets in increasing doses for the first month until their individual
maximum tolerated dose is established, which will continue at that level
for the rest of the treatment phase. Monthly clinic visits required for
examination and MRI scans. Following the treatment phase, monthly exams
and MRIs will be required for 3 months. Some of the evaluations will include
drawing blood and collecting urine. Lumbar puncture (spinal tap) and leukapheresis
each will be done twice.
Benefit: May lead to a new treatment for RRMS and SPMS.
For Information: Contact the NIH Patient Recruitment and Public
Liaison Office via toll-free telephone at (800) 411-1222, or via e-mail:
prpl @ mail.cc.nih.gov.
Schwann Cell Transplantation as a Reparative Therapy for MS
Location: Yale MS Research Center, New Haven, CT
Purpose: To test the potential of Schwann cells as a replacement of
myelin in MS plaques.
Eligibility: Male and female patients with advanced MS; must
live within 100 miles of New Haven.
Procedures: This Phase I study requires a small number of test
subjects (up to five). Schwann cells will be isolated from a piece of the
participant’s own nerve cell (sural nerve biopsy) and then implanted into
the brain.
Benefit: This is a Phase I study, a first step in development
of myelin repair treatment. The study will not lead to improvement of function.
For Information: Contact Dr. Jana Preiningerova at the Yale
MS Research Center, (203) 764-4291, or via e-mail: Jana.Preiningerova@yale.edu.
Total-Body Irradiation, Anti-Thymocyte Globulin and Cyclophosphamide Followed by Syngeneic or Autologous Peripheral Blood Stem Cell Transplantation in Patients With MS
Location: Multiple locations in the US; based in Seattle, WA
Purpose: Phase I pilot study to:
• Determine the toxicity of total-body irradiation, anti-thymocyte
globulin, and cyclophosphamide followed by syngeneic or autologous blood
stem cell (PBSC) transplantation in patients with MS
• Determine the disease response of patients treated with this regimen
• Determine the safety and efficacy of filgrastim (G-CSF) for PBSC
mobilization in this population.
Eligibility:
• Men and women aged 18 to 60 years
• Diagnosis of rapidly progressive MS by Poser criteria and at high
risk for a fatal outcome or severe disability with one of the following:
primary progressive disease, relapsing-remitting disease with two or more
attacks in 2 years, secondary progressive disease
• EDSS between 5.0 and 8.0 with deterioration in the EDSS of 1 or more
points over the past year
• More than 60 days since relapse of MS
• Sibling donor proven to be an identical twin by ABO typing, HLA typing,
and VNTR analysis (for syngeneic transplantation)
Procedures: Patients receive oral prednisone on days 0 to 10.
Beginning on day 1, undergo autologous PBSC transplantation and receive
G-CSF subcutaneously daily until leukapheresis is completed. Leukapheresis
begins on approximately day 4 and continues until adequate CD34+PBSC are
collected. PBSC are collected from syngeneic donors in a similar manner.
Patients undergo total body irradiation twice daily on days –5 and –4.
Patients receive cyclophosphamide IV on days –3 and –2 and anti-thymocyte
globulin IV on days –5, –3, –1, 1, 3, and 5. Patients undergo autologous
or syngeneic PBSC transplantation on day 0. Following PBSC transplantation,
receive oral prednisone on days 7 to 30 and G-CSF IV daily beginning on
day 0 and continuing until blood counts recover. Patients are followed
at 30, 80, and 90 days, monthly for 6 months, and then at 1 and 2 years.
Benefit: This study may lead to a new treatment for progressive
MS.
For Information: Contact Richard Nash at the Fred Hutchinson
Cancer Research Center in Seattle, WA, at (206) 667-4978.
Utility of Automated Neuropsychological Assessment for Evaluation of Cognitive Dysfunction and Assessment of Cognition in RRMS Treated With Avonex®
Location: University of Virginia, Charlottesville, VA
Purpose: To compare results from an automated battery of neuropsychological
measures with traditional neuropsychological paper/pencil tests; to assess
correlation between physical symptoms (EDSS scores) and cognitive symptoms
in patients on Avonex, as well as cognition over time in patients on Avonex
and in controls.
Eligibility: Men and women ages 18 to 60 with diagnosis of relapsing-remitting
MS, initiating therapy with Avonex, and an EDSS between 1.0 and 5.5. There
are exclusion criteria, which will apply to both groups.
Procedures: Participants will be evaluated five times over 2
years at 6-month intervals. Patients with MS must have first evaluation
before initiating Avonex, and will have brief physical assessment at each
visit. Testing takes about 3 hours and looks at areas of memory, mental
processing speed, attention, and executive functioning. No normal treatments
will be omitted and patients can be treated for exacerbations.
Benefit: Participants will be paid for completed visits.
For Information: Contact Lorie Elder at the University of Virginia
School of Medicine Clinical Trials Office via telephone at (434) 924-8530,
or via e-mail: uvaclintrials @ virginia.edu.
Zenapax® to Treat MS
Location: National study sponsored by the NINDS in Bethesda,
MD
Purpose: To examine the safety and effectiveness of Zenapax
(a laboratory-manufactured antibody) in treating MS.
Eligibility:
• Women and men aged 18 to 65 years
• Persons with relapsing-remitting or secondary progressive MS who
have had more than one relapse within 18 months preceding study enrollment
• EDSS score between 2.5 and 6.5, inclusive
• Have failed standard IFN-beta therapy
• Must have at least 2 Gd-enhancing lesions or greater in the three
pre-treatment MRI scans (an average of at least 0.67 Gd-enhancing lesions/scan)
Procedures: Three MRI scans over initial 2 months to evaluate
disease activity. During treatment, receive seven IV infusions of Zenapax––the
first two will be given 2 weeks apart; the next five will be given once
a month. Before each infusion, participants will have two MRI scans, one
using standard procedure and one using gadolinium. Blood and urine samples
will be taken at each visit. There will be skin tests. A lumbar puncture
will be done at the beginning and at end of the treatment phase. Lymphocytes
will be collected before, during, and after treatment.
Benefit: May lead to a new treatment for RRMS or SPMS.
For Information: Contact the NIH Patient Recruitment and Public
Liaison Office, via toll-free telephone at (800) 411-1222
Copyright © MSQR 2002